Prochlorperazine Maleate

Product NDC
70710-1668
11-digit product format
707101668
Labeler code
70710
Product ID
70710-1668_da187256-50af-400b-ab27-a073f3fbe81a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA216495
Marketing category
ANDA
Marketing start
2022-08-10
Substance
PROCHLORPERAZINE MALEATE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prochlorperazine Maleate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE MALEATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1T8O1JTL6
Rxcui198365, 312635

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfe4595-32b8-9175-3af8-875e9c4c0538Product name620260305
7335ddeb-6cbd-135c-487d-96fa4587ad65Product name620250331
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1668-1Prochlorperazine Maleate100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1668-1EA - Each70710-1668a57965d5-9872-4c53-b367-60e161fa050b12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1668PROCHLORPERAZINE MALEATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]6Current NDC, Legacy NDC, 1 package rows20241207_d4a34138-a01b-418f-8e0f-e81f6e1cfd89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN5c1dd0ea-89e9-4317-a83e-5e15da79ca206
198365prochlorperazine maleate 10 MG Oral TabletPSNd4a34138-a01b-418f-8e0f-e81f6e1cfd896
312635prochlorperazine maleate 5 MG Oral TabletPSNd4a34138-a01b-418f-8e0f-e81f6e1cfd896
198365prochlorperazine 10 MG Oral TabletSCD5c1dd0ea-89e9-4317-a83e-5e15da79ca206
198365prochlorperazine 10 MG Oral TabletSCDd4a34138-a01b-418f-8e0f-e81f6e1cfd896
312635prochlorperazine 5 MG Oral TabletSCDd4a34138-a01b-418f-8e0f-e81f6e1cfd896
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY5c1dd0ea-89e9-4317-a83e-5e15da79ca206
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSYd4a34138-a01b-418f-8e0f-e81f6e1cfd896
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSYd4a34138-a01b-418f-8e0f-e81f6e1cfd896
198365prochlorperazine maleate 10 MG Oral TabletPSN115a4125-07df-9f9b-e063-6394a90a3e493
198365prochlorperazine 10 MG Oral TabletSCD115a4125-07df-9f9b-e063-6394a90a3e493
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY115a4125-07df-9f9b-e063-6394a90a3e493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1668-170710166801100 TABLET in 1 BOTTLE (70710-1668-1) 100 tablet2022-08-100000-00-00NoNoCurrent